Guest Columns

1. Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach 11/14/2025

   Here's a blueprint for transforming the fragmented, high-risk interface between vector and cell therapy platforms into a unified, predictable, and compliant system.

2. Exploring The Benefits Of Electroporation In NK Cell Transfection 11/14/2025

   Electroporation creates temporary holes in cell membranes for genetic material to slip through. The technique offers some key advantages to viral transduction.

3. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

   When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.

4. It's Not Just You, Everyone's Talking About OPV 11/12/2025

   Ongoing process verification has evolved beyond a compliance exercise to a strategic priority thanks, in part, to technology advancements.

5. Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs 11/6/2025

   This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process. 

6. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

   The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

7. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

   Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.

8. Why Do So Few Cell Therapies Make The Leap From Lab To GMP? 11/5/2025

   Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.

9. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

10. The Transition To E-Labeling Is More Than Uploading PDFs 10/31/2025

    Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.